Development and Pilot Test of a Postnatal mHealth Intervention - Phase 2 (MESSAGE)

Development and Pilot Test of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health - Phase 2

The goal of the study is to assess the feasibility and acceptability of the optimized MeSSSSage intervention which was developed and revised based on the results of our initial pilot testing. The investigators will conduct a controlled 4-arm factorial design randomized study to test the feasibility, acceptability and preliminary effectiveness of several intervention modalities over a 6-month period.

Study Overview

• Status: Completed
• Conditions: Health Attitude; Post Partum Depression; Knowledge, Attitudes, Practice; Acceptability of Health Care
• Intervention / Treatment: Behavioral: MESSSSAGE - live; Behavioral: MESSSSAGE - asynchronous

Detailed Description

Most mHealth interventions for maternal and child health (MCH) in low and middle-income countries, including India, have focused on unidirectional and non-interactive approaches, primarily text messaging. However, ample evidence suggests that provider-led, interactive educational programming and social support are key for improving health behaviors and outcomes. Thus innovative mHealth approaches that promote interactive education and facilitate social support have great potential to improve MCH outcomes. The two-phase development of MeSSSSage include sPhase 1: exploratory development on functions and platforms and Phase 2: a mixed-methods randomized pilot study using a factorial design of specific intervention functions and platforms confirmed in Phase 1. Study activities described herein are associated with Phase 1. The study's specific aim is: To test the optimized intervention to understand the feasibility, acceptability and preliminary effectiveness of several intervention modalities among postnatal women in rural India. In Phase 2, the investigators conduct a randomized factorial design to understand the contribution to various intervention modalities on feasibility, accessibility and preliminary effectiveness. Data are collected via quantitative participant survey (baseline and endline) including sociodemographic characteristics and knowledge about maternal and infant health, self-efficacy, and perceived social norms regarding MCH-related health promoting behaviors (baseline) acceptability questions such as women's satisfaction with and perceptions of MeSSSSage, maternal and infant knowledge-, behavior-, and health-related questions including about breastfeeding, complementary food introduction, immunization, family planning uptake, maternal physical and mental health, etc. The investigators will validate self-report with health records. The investigators will conduct in-depth interviews among a purposive sample of 30 women to understand: mobile technology familiarity prior to intervention, perspectives on intervention and challenges, structure of intervention (group, individual), content, perspectives on the text-based component, relationship with other participants, perspective on the moderator, postnatal period health related concerns, sources of support (social and informational), recommendations. Other assessment will include technological data from, and group moderator surveys and interviews.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India
    • Post Graduate Institute for Medical Education and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Postnatal (within 2 weeks)
• 18+ years old

Exclusion Criteria:

• Women below 18 years of age
• Women with high risk pregnancies
• Women who delivered preterm, suffer severe maternal complications or they or their baby are otherwise sick in the first week

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: live support; Real-time live voice call plus standard of postnatal care.	Behavioral: MESSSSAGE - live; mHealth education and social support intervention, synchronous via call
Experimental: Arm 2: asynchronous support; Text-based, asynchronous, on-demand social support plus standard of postnatal care	Behavioral: MESSSSAGE - asynchronous; mHealth education and social support intervention, asynchronous via text
Experimental: Arm 3: both live and asynchronous support; Real-time live voice call plus standard of postnatal care; text-based, asynchronous, on-demand social support plus standard of postnatal care	Behavioral: MESSSSAGE - live; mHealth education and social support intervention, synchronous via call; Behavioral: MESSSSAGE - asynchronous; mHealth education and social support intervention, asynchronous via text
No Intervention: Arm 4: control; Standard of postnatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience	Number of participants reporting being "satisfied" or "very satisfied" with their overall intervention experience, assessed through a five-point Likert scale at six months.	6 months
Number of Participants Engaging in Group Call Intervention	Number of participants who engaged in weekly group call intervention activities by 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.	Number of participants correctly identifying at least 80% of knowledge on maternal and neonatal danger signs, best practices for infant care, and family planning at 6 months.	6 months
Number of Participants Exclusively Breastfeeding	Number of participants who exclusively breastfed their infants through 6 months of age	6 months
Number of Participants Reporting Postpartum Depression	Number of participants reporting postpartum depression symptoms at six months	6 months
Number of Participants Who Adopted Postpartum Family Planning	Number of participants who started a modern contraceptive methods within 6 months postpartum	6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of California, Los Angeles; Post Graduate Institute of Medical Education and Research, Chandigarh; Indraprastha Institute of Information Technology Delhi; Survival for Women and Children Foundation
• Investigators: Principal Investigator: Alison M El Ayadi, ScD, University of California, San Francisco; Principal Investigator: Nadia G Diamond-Smith, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression, Postpartum
• Other Study ID Numbers: R21HD101786-A; R21HD101786 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No